Month: June 2013

The recent Supreme Court decision striking down the patenting of naturally occurring genes is being hailed as a victory for patients and healthcare providers, because sky-high licensing fees can no longer be charged by companies holding a monopoly on genetic information. Some biotech companies are down in the dumps, however, as they fear smaller returns on discoveries and thus lower incentives to develop new gene tests. The BRCA1 and BRCA2 tests at the center of the SCOTUS case, developed and licensed exclusively by Salt Lake City-based Myriad Genetics, helped propel Myriad’s 2012 earnings to a snip shy of half a billion dollars–equal to the GDP of the British Virgin Islands, which has much better rum drinks than Utah.

Avaris Pharmaceuticals–based, conveniently, under a tax-sheltering palm tree in the British Virgin Islands–has announced a bold new strategy it hopes will become a new industry standard for gouging providers and patients alike: gene trademarks.

Using a variety of newly available technologies, Avaris plans to “brand” genes to give them a distinctive look and feel. Traditional pharmaceuticals have used this approach since the mid-20th century. The color and shape of a pill is known in the industry as “trade dress.” Think Zantac’s blue pentagon, Viagra’s blue diamond, or the “purple pill,” Prilosec. The physician and historian of medicine Jeremy Greene has discussed how trade dress is used to instill confidence on the part of doctors and, with direct-to-consumer marketing, patients themselves. But can Avaris really create “trade dress” for genes?

“We can create a trade dress for genes,” said Ray P. N. Pillage, a senior scientist at Avaris. Pillage offered several scenarios by which trademarked genes could become a reality. One is fluorescent labeling. Fluorescence In Situ Hybridization (FISH) has been in use since the 1990s as a technique for staining whole chromosomes. Avaris scientists are working on ways to create microscopic logos on engineered chromosomes that carry particular genes. By placing a sample under a special microscope, a routine technician could check that a chromosome carried a particular gene. Pillage imagines a host of attention-getting devices that could usher in a colorful era of flashing, flickering chromosomes, reminiscent of the golden age of neon storefront signs of the early 20th century. “It’ll be like Times Square in a dish,” said Pillage.

Another technique could involve radioactive labeling of individual nucleotides. This is an even older technique that dates back to the years immediately after World War II. Substituting hot isotopes of phosphorus, nitrogen, carbon, and hydrogen for their non-radioactive atomic counterparts could enable researchers to create intricate patterns in the DNA itself. Specific forms of naturally occurring genes could be labeled with unique eye-catching designs and even logos. “We might even be able to embed subliminal messages,” said Pillage, his eyes widening and little flecks of saliva appearing in the corners of his mouth. “You know, like when they spliced a single frame of a Coca-Cola into a movie and suddenly you felt thirsty?” An intrepid reporter takes the bait: “So, you’ll make technicians want a soft drink?” “No, that’s small potatoes–and anyway a different market niche. We’ll make you think, ‘Say, a high-Speed sEquencing machine would be eXcellent! And PErhaps a New In Situ fluorescence microscope!'”

For now, trademarked genes would not be marketed to the public. Branded DNA would be delivered, ice cold, to genetic testing laboratories and biotech companies seeking to develop new tests. The hope is that the labeled genes will inspire confidence that the DNA is the “real thing.” If the product can be trusted to have zero impurities, Pillage said, “things will go better” in the lab.

The beauty of trademarking, from a marketing point of view, is that in modifying the DNA, it then becomes patentable–even though no biological activity is introduced to the molecule. It will respond to the same genetic tests. By dressing up the DNA, furthermore, industry executives hope to instill the same sense of confidence trade dress confers in pharmaceuticals. It seems likely that a new “generic DNA” industry will follow suit, providing a lower-cost–but perhaps lower trust–alternative to “name brand” genes.

“It’ll be a goldmine,” said Pillage, reaching into a company refrigerator. “Have a Coke?”